ISTH Academy

PB0562

Gender-related Differences in Venous Thromboembolism Patients: GARFIELD-VTE

P. Prandoni¹, A.G.G. Turpie², A.E. Farjat³, J.I. Weitz⁴, S. Haas⁵, W. Ageno⁶, S.Z. Goldhaber⁷, S. Goto⁸, P. Angchaisuksiri⁹, J. Dalsgaard Nielsen¹⁰, G. Kayani³, S. Schellong¹¹, H. Bounameaux¹², L. Mantovani¹³, A.K. Kakkar³, on behalf of the GARFIELD-VTE investigators
¹Arianna Foundation on Anticoagulation Bologna, Selvazzano Dentro, Italy, ²Master University, Hamilton, Canada, ³Thrombosis Research Institute, London, United Kingdom, ⁴McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada, ⁵Formerly Technical University of Munich, Munich, Germany, ⁶University of Insubria, Department of Medicine and Surgery, Varese, Italy, ⁷Harvard Medical School, Boston, United States, ⁸Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, ⁹Ramathibodi Hospital, Mahidol University, Department of Medicine, Salaya, Thailand, ¹⁰Copenhagen University Hospital, Copenhagen, Denmark, ¹¹Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, ¹²University Hospital of Geneva and Faculty of Medicine, Geneva, Switzerland, ¹³University degli Studi di Milano Bicocca, Milan, Italy

Main Topic: Venous Thromboembolism
Category: VTE Risk Factors

Background: Venous thromboembolism (VTE) is a common cause of morbidity and mortality worldwide. There is a paucity of research investigating the influence of gender on characteristics, treatment patterns and outcomes in VTE patients.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month clinical outcomes between males and females treated with anticoagulation therapy in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 9,709 of which (male n=4897, female n=4812) received anticoagulation therapy and were eligible for analysis in this study.
Results: The distribution of VTE events was comparable (Male: 61.5% deep vein thrombosis (DVT) alone, 38.5% pulmonary embolism (PE) ± DVT; Female: 61.9% DVT alone, 38.1% PE ± DVT). Males and females were similar in both age; mean (standard deviation) 57.6 (15.7) years vs. 57.4 (18.0) years and BMI; mean (standard deviation) 27.9 (5.5) kg/m² vs. 28.9 (7.5) kg/m², respectively. Males were more likely to be a current/previous smoker (55.0% vs. 22.6%), but less likely to have been chronically immobilized (4.6% vs. 6.4%) or experienced a recent bleed/anaemia (2.1% vs. 4.5%). No clinically meaningful differences were found between anticoagulation treatment patterns at baseline between genders (Table 1). Over 12-months follow-up, event rates (95% confidence intervals) of all-cause mortality and recurrent VTE in males (vs females) were similar: 6.91 (6.18-7.72) vs 7.55 (6.77-8.40) and 5.02 (4.40-5.73) vs. 4.68 (4.08-5.38) per 100 person-years, respectively. Major and overall bleeding were significantly more frequent in females compared to males (1.32 (1.02 - 1.71) vs 1.91 (1.54 - 2.37) and 12.71 (11.66-13.85) vs. 8.67 (7.83-9.60), respectively (Table 2)).
Conclusions: Despite no differences in anticoagulation treatment at baseline, female VTE patients have an increased risk of bleeding compared to males over 12-months follow up.